National Trends in Nonoperative Management of Rectal Adenocarcinoma

2016 ◽  
Vol 34 (14) ◽  
pp. 1644-1651 ◽  
Author(s):  
Clayton Tyler Ellis ◽  
Cleo A. Samuel ◽  
Karyn B. Stitzenberg
Keyword(s):  
Rectal Cancer ◽  
Nonoperative Management ◽  
Rectal Adenocarcinoma ◽  
High Volume ◽  
Complete Response ◽  
Neoadjuvant Chemoradiation ◽  
Facility Level ◽  
National Trends ◽  
Incident Cases ◽  
Over Time

Purpose Neoadjuvant chemoradiation for stage II/III rectal cancer results in up to 49% of patients with a clinical complete response. As a result, many have questioned whether surgery can be omitted for this group of patients. Currently, there is insufficient evidence for chemoradiation only, or nonoperative management (NOM), to support its adoption. Despite this, anecdotal evidence suggests there is a trend toward increased use of NOM. Our objective was to examine the use of NOM for rectal cancer over time, as well as the patient- and facility-level factors associated with its use. Methods We included all incident cases of invasive, nonmetastatic rectal adenocarcinoma reported to the National Cancer Database from 1998 to 2010. We performed univariate and multivariate analyses to assess for NOM use over time, as well as associated patient- and facility-level factors. Results A total of 146,135 patients met the inclusion criteria: 5,741 had NOM and 140,394 had surgery with or without additional therapy. From 1998 to 2010, NOM doubled, from 2.4% to 5% of all cases annually. Patients who were black (adjusted odds ratio [AOR], 1.71; 95% CI, 1.57 to 1.86), uninsured (AOR, 2.35; 95% CI, 2.08 to 2.65) or enrolled in Medicaid (AOR, 2.10; 95% CI, 1.90 to 2.33), or treated at low-volume facilities (AOR, 1.53; 95% CI, 1.42 to 1.64) were more likely to receive NOM than were patients who were white, privately insured, and treated at a high-volume facility, respectively. Conclusion NOM demonstrates promise for the treatment of rectal cancer; currently, however, the most appropriate strategy is to pursue this approach with well-informed patients in the context of a clinical trial. We observed evidence of increasing NOM use, with this increase occurring more frequently in black and uninsured/Medicaid patients, raising concern that increased NOM use may actually represent increasing disparities in rectal cancer care rather than innovation. Further studies are needed to assess survival differences by treatment strategy.

Innovation or disparity? National trends in nonoperative management of rectal adenocarcinoma.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 688-688 ◽  
Author(s):  
Clayton Tyler Ellis ◽  
Cleo A. Samuel ◽  
Karyn B. Stitzenberg
Keyword(s):  
Rectal Cancer ◽  
Rectal Adenocarcinoma ◽  
High Volume ◽  
Complete Response ◽  
Operative Management ◽  
National Cancer Data Base ◽  
Cancer Data ◽  
Facility Level ◽  
Incident Cases ◽  
Over Time

688 Background: While surgical resection has always been the cornerstone of curative treatment for rectal cancer, preoperative chemoradiation for stage II/III rectal cancer results in up to 49% of patients with a clinical complete response. As a result, many have questioned whether surgery can be omitted for this group of patients. Currently, there is insufficient evidence on the safety and efficacy of chemoradiation-only, or non-operative management (NOM), to support the wholesale adoption of this treatment paradigm. Despite this, anecdotal evidence suggests there is a trend for increased use of NOM. Our objective was to examine trends in the use of NOM for rectal cancer over time as well as patient- and facility-level factors associated with its use. Methods: We included all incident cases of invasive, non-metastatic, rectal adenocarcinoma reported to the National Cancer Data Base (NCDB) from 1998–2010. We performed univariate and multivariate analyses to assess NOM use over time as well as patient- and facility-level predictors of NOM. Results: 146,135 patients met inclusion criteria: 5,741 had NOM and 140,394 had surgery +/- additional therapy. From 1998-2010, the use of NOM doubled from 2.4% to 5% of all cases annually. Patients who were Black (AOR=1.71, 95%CI=1.57-1.86), uninsured (AOR=2.35, 95%CI=2.08-2.65), Medicaid-enrolled (AOR=2.10, 95%CI=1.90-2.33), and those treated at low-volume facilities (AOR=1.53, 95%CI=1.42-1.64) were more likely to receive NOM than White, privately insured, and high-volume facility patients, respectively. Additionally, NOM was more common in the South (AOR=1.53, 95%CI=1.32-1.76) and Pacific (AOR=1.82, 95%CI=1.57-2.12) as compared with the Northeast. Conclusions: NOM is an innovative approach that demonstrate promise in the treatment of rectal cancer. Pursing this approach in the context of a clinical trial and with well-informed patients would be appropriate. We observed evidence of increasing NOM utilization; however, this increase is occurring more frequently in Black and uninsured/Medicaid patients, raising concern that increased NOM use may actually represent increasing disparities in rectal cancer care rather than innovation.

Predictors of rectal cancer resection at high-volume hospitals among Medicare patients.

2018 ◽  
Vol 36 (4_suppl) ◽  
pp. 808-808
Author(s):  
Mary E. Charlton ◽  
Catherine Chioreso ◽  
Irena Gribovskaja-Rupp ◽  
Chi Lin ◽  
Marcia M Ward ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Rectal Adenocarcinoma ◽  
High Volume ◽  
Neoadjuvant Chemoradiation ◽  
Sphincter Preservation ◽  
Cancer Center ◽  
Medicare Beneficiaries ◽  
Co Morbidity ◽  
High Volume Hospital ◽  
Low Volume

808 Background: Hospitals that perform high volumes of rectal cancer resections achieve superior rates of sphincter preservation and survival compared to those that do not, but many rectal cancer resections are still performed in low-volume centers. We aimed to determine the patient, provider and pathway characteristics associated with receipt of surgery from high-volume hospitals. Methods: Patient and provider characteristics were extracted from the SEER-Medicare database for Medicare beneficiaries (age 66+) with stage II/III rectal adenocarcinoma diagnosed 2007-2011 who received rectal cancer-directed surgery. Hospitals were divided into quartiles by volume of rectal cancer resections, and were also classified by NCI cancer center designation. Results: 2056 patients were included, and 57% received surgery in a high-volume hospital or NCI-designated center. Those residing in census tracts classified as rural and having higher median incomes, lower poverty, and higher levels of education more frequently received surgery in high-volume hospitals; there were no differences by age, gender, stage, or co-morbidity status. 55% of patients received surgery at the same facility where they received the colonoscopy that identified their cancer. In multivariate analyses, the strongest predictor of receiving one’s surgery in a high-volume hospital was receipt of colonoscopy at a high-volume facility (OR = 3.75, 95% CI: 2.93-4.79). Those treated in high-volume hospitals more often had guideline-recommended staging (TRUS/MRI) and treatment (neoadjuvant chemoradiation). Conclusions: Rectal cancer patients tended to stay at the facility where their cancer was diagnosed; and did not typically seek out high-volume providers if their colonoscopy was performed in a low-volume facility. This suggests that colonoscopists may have substantial influence over where patients receive surgery. Given that rurality, income and education appear to more strongly predict receipt of surgery at a high-volume hospital compared to clinical characteristics, further research is needed to understand considerations driving patient decisions and referring providers’ recommendations for care.

A multicenter phase Ib/II study of DNA-PK inhibitor peposertib (M3814) in combination with capecitabine and radiotherapy in patients with locally advanced rectal cancer.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. TPS144-TPS144
Author(s):  
Paul Bernard Romesser ◽  
Emma B. Holliday ◽  
Tony Philip ◽  
Rocio Garcia-Carbonero ◽  
Jaume Capdevila ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Colon Cancer ◽  
Phase Ii ◽  
Locally Advanced ◽  
Neoadjuvant Treatment ◽  
Rectal Adenocarcinoma ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer ◽  
Phase Ib

TPS144 Background: Perioperative radiotherapy and chemotherapy, followed by total mesorectal excision, is the standard of care for patients with locally advanced rectal cancer (LARC). However, 1/3 of these patients still develop distant metastases, indicating the need for more effective therapies. In addition, strategies that increase pathological complete response rates are needed to enable non-surgical management of LARC. DNA-dependent protein kinase (DNA-PK) regulates a key DNA damage repair pathway for double-strand break repair. Peposertib (M3814), a potent, selective, orally administered DNA-PK inhibitor, has been shown to potentiate the effect of ionizing radiation in a human colon cancer xenograft model and several colon cancer cell lines. Peposertib is being investigated in several different trials across multiple indications. This Phase Ib/II study (NCT03770689) aims to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of the neoadjuvant treatment combination of peposertib, capecitabine, and radiotherapy (RT) in patients with LARC. Methods: Patients aged ≥18 years with histologically confirmed and resectable Stage II/III rectal adenocarcinoma are eligible. Induction chemotherapy is permitted, but residual disease must first be documented by MRI, digital rectal examination and endoscopy. Patients who received other anticancer therapies or those with prior pelvic RT are excluded. At open-label Phase Ib (open), 18–30 patients (n = 3 per cohort) will receive peposertib + capecitabine (orally, 825 mg/m2 twice daily [BID]) + RT (45–50.4 Gy), 5 days/week. Peposertib 50 mg once daily (QD) was the starting dose. Additional dose levels will range between 100─800 mg QD. Dose escalation is determined by the safety monitoring committee and guided by a Bayesian 2-parameter logistic regression model. At Phase II (planned), 150 patients will be randomized (1:1) to receive oral capecitabine (825 mg/m2 BID) + RT (45–50 Gy), with either oral peposertib (recommended phase II dose [RP2D] or placebo, QD for 5 days/week. Primary objectives are to define a maximum tolerated dose and RP2D (Phase Ib), and to evaluate the efficacy of peposertib + capecitabine + RT in terms of pathological/clinical complete response (Phase II). Secondary objectives include assessment of antitumor activity (Phase Ib), quality of life outcomes (Phase II), and PK of peposertib, and the safety and tolerability of the combination therapy (both phases). To date, one patient has received peposertib 50 mg QD, six patients peposertib 100 mg QD, three patients peposertib 150 mg QD, and three patients peposertib 250 mg QD. Clinical trial information: NCT03770689.

Pilot Study of Patients’ Preferences for Immediate Resection Versus a Watch and Wait Approach After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer

2020 ◽  
pp. OP.20.00158
Author(s):  
Ashray Gunjur ◽  
Grace Chazan ◽  
Genni Newnham ◽  
Sue-Anne McLachlan
Keyword(s):  
Rectal Cancer ◽  
Locally Advanced ◽  
Survival Rates ◽  
Complete Response ◽  
Advanced Rectal Cancer ◽  
Recurrence Risk ◽  
Locally Advanced Rectal Cancer ◽  
Neoadjuvant Chemoradiation ◽  
Watch And Wait ◽  
Time Tradeoff

PURPOSE: In patients with rectal cancer who achieve a clinical complete response to neoadjuvant chemoradiation, it may be reasonable to adopt a watch-and-wait (W&W) strategy rather than proceed to immediate resection of the rectum. Patient preferences for this strategy are unknown. The primary aim of the current study was to determine the feasibility of assessing hypothetical recurrence and survival differences that relevant patients would tolerate to avoid immediate resection of the rectum. A secondary aim included estimating patients’ tolerance thresholds and the factors that might predict them. METHODS: We developed a study-specific written questionnaire based on a previously validated instrument. Hypothetical time tradeoff tasks were used to determine the recurrence rate patients would accept to adopt a W&W strategy and the survival benefit that would be needed to justify choosing immediate resection over W&W. Feasibility was measured on the basis of response rate, the stated ease of completion and the satisfaction of task, and time used. RESULTS: Twenty of 31 potentially eligible patients completed the study-specific questionnaire. The majority of respondents felt that questions were clear (70%) and not hard to understand (65%). The median acceptable recurrence risk to adopt a W&W strategy was 20% (interquartile range [IQR], 10%-35%). Patients required a median of 2.0 extra years of survival (IQR, 1.0-3.0 years) over a baseline 7.0 years, and they required a median extra 10% (IQR, 4%-19%) over baseline 70% survival rates to justify immediate resection. CONCLUSION: Measuring the preferences of patients with rectal cancer using time tradeoff methods seemed to be feasible. Larger studies are needed to confirm how acceptable a W&W strategy would be for relevant patients.

scholarly journals Time to surgery and pathologic complete response after neoadjuvant chemoradiation in rectal cancer: A population study on 2094 patients

2017 ◽  
Vol 4 ◽  
pp. 8-14 ◽  
Author(s):  
Gabriella Macchia ◽  
Maria Antonietta Gambacorta ◽  
Carlotta Masciocchi ◽  
Giuditta Chiloiro ◽  
Giovanna Mantello ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Population Study ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Neoadjuvant Chemoradiation ◽  
Time To Surgery

EXPERT-C: A randomized phase II European multicenter trial of neoadjuvant chemotherapy (capecitabine/oxaliplatin) and chemoradiation (CRT) with or without cetuximab followed by total mesorectal excision (TME) in patients with MRI-defined high-risk rectal cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 360-360 ◽  
Author(s):  
A. Dewdney ◽  
D. Cunningham ◽  
J. Tabernero ◽  
B. Glimelius ◽  
A. Cervantes ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
High Risk ◽  
Neoadjuvant Chemotherapy ◽  
Performance Status ◽  
Rectal Adenocarcinoma ◽  
Complete Response ◽  
R0 Resection ◽  
Wild Type ◽  
Braf Mutations ◽  
Secondary Endpoints

360 Background: We previously demonstrated the feasibility of administering neoadjuvant chemotherapy before CRT and TME in patients with MRI selected poor prognosis rectal cancer (Chua Y J et al Lancet Oncol 2010). This trial evaluates the addition of the anti-EGFR antibody cetuximab to this treatment strategy. KRAS and BRAF mutations have been established as predictive for lack of response to anti-EGFR therapy in metastatic colorectal cancer. Methods: Patients with newly diagnosed, histologically confirmed, MRI defined high risk rectal adenocarcinoma were randomised to receive 4 cycles of capecitabine 1,700mg/m2 with oxaliplatin 130mg/m2 (CAPOX) followed by CRT, 45Gy/25# + 5.4Gy/3# boost with concurrent continuous capecitabine 1,650mg/m2/day, TME and 4 cycles of adjuvant CAPOX (EXPERT) or the same regimen with the addition of cetuximab (400mg/m2 loading dose week 1, followed by 250mg/m2/week) (EXPERT-C). The primary endpoint is complete response (CR) (defined as pathological complete response or radiological complete response in patients who decline surgery) in KRAS and BRAF wild type tumours. Secondary endpoints include radiological response to CRT, CR in both KRAS wild type and mutant patients, R0 resection rates, progression free and overall survival and safety. Results: Between 2005-2008, 165 eligible patients were recruited from 15 centres (EXPERT n=81, EXPERT-C n=84). 99% of patients had performance status 0-1, 98% had ≥ T3 disease, 56% had an involved or threatened circumferential resection margin and 72% had evidence of extramural venous invasion determined by MRI. The current median follow up is 30 months. 72/81 (89%) and 79/84 (94%) of patients completed neoadjuvant CRT and 72/81 (89%) and 77/84 (92%) patients underwent curative-intent surgery on the EXPERT and EXPERT-C arms respectively. Two patients declined surgery. Conclusions: The primary and secondary endpoints will be analyzed in October 2010 and will be presented at the meeting. [Table: see text]

Effect of postoperative chemotherapy (CT) on survival in patients (pts) with resected rectal cancer who received neoadjuvant therapy.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14535-e14535
Author(s):  
Christina Sing-Ying Wu ◽  
Lai Wei ◽  
Katherine Glass ◽  
John Wilson ◽  
Sherif Abdel-Misih ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Survival Benefit ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Neoadjuvant Chemoradiation ◽  
Wilcoxon Test ◽  
Stage Ii ◽  
Categorical Variables ◽  
Rank Test ◽  
Significant Difference

e14535 Background: Pts with stage II/III rectal cancers are treated with neoadjuvant chemoradiation and surgical resection followed by adjuvant CT per practice guidelines. It is unclear whether adjuvant CT provides survival benefit, and the purpose of this study was to measure outcome in pts who did and did not receive adjuvant CT. Methods: We used a prospectively collected database for pts treated at The Ohio State University and analyzed overall survival (OS), time to recurrence (TTR), pt characteristics, tumor features, and treatments. Survival curves were estimated using Kaplan-Meier method and compared by the log-rank test. Age was compared using the Wilcoxon test, and other categorical variables were compared using Chi-square test or Fisher’s exact test. Results: Between August, 2005 to July, 2011, 110 pts were identified and 71 pts had received adjuvant CT. There was no significant difference in sex, race, pathologic tumor (T) stage, and pathologic complete response between the two groups. Pts receiving adjuvant CT were significantly younger (median age 54.3 vs. 62 years, p=0.01) and had more advanced pathologic nodal (N) stage (43 vs. 19% N1 or N2, p=0.02). Median OS was 72.6 months with CT vs. 36.4 months without CT (p=0.0003). Median TTR has not yet been reached. Conclusions: In this retrospective analysis, adjuvant CT was associated with a longer OS despite more advanced pathologic nodal staging. Prospective randomized studies are warranted to determine whether adjuvant CT provides a survival benefit for pts across the spectrum of stage II and III rectal cancer. [Table: see text]

Assessment of macroscopic features in relation to tumor response to neoadjuvant chemoradiation therapy in rectal cancer.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 507-507
Author(s):  
Amanda Kathleen Arrington ◽  
Julio Garcia-Aguilar ◽  
Marjun Philip Duldulao ◽  
Carrie Luu ◽  
Julian Sanchez ◽  
...  
Keyword(s):  
Rectal Cancer ◽  
Tumor Response ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Complete Response ◽  
Neoadjuvant Chemoradiation ◽  
Chemoradiation Therapy ◽  
Oncologic Outcomes ◽  
Neoadjuvant Chemoradiation Therapy ◽  
Pathologic Features

507 Background: Several studies show locally advanced rectal cancer patients with clinical complete response (cCR) have comparable oncologic outcomes to pathologic complete response (pCR) to neoadjuvant chemoradiation therapy (NCRT). Thus, total mesorectal excision (TME) could potentially be avoided. Our objective was to validate macroscopic features of cCR. Methods: 164 patients with stage II/III rectal cancer were previously enrolled in a phase II trial and treated by NCRT and TME. Tumor response in the surgical specimens was assessed according to AJCC guidelines. A pCR was defined as absence of viable tumor cells. Gross macroscopic features by the pathologist were tabulated and our cohort was applied to previously published cCR criteria. Results: 25.0% (n = 41) had pCR; 75.0% (n = 123) had non-pCR. Descriptors were condensed into 14 macroscopic features by combining terms and excluding those rarely mentioned. Several reports affirm that scarring signifies cCR, while others suggest that fibrosis, edema, ulceration and nonpalpable tumor to be consistent with cCR. In our study, scarring was found in 6.1% of patients, 16.7% of which had pCR. We found that hyperemia, scarring, flat, smooth, and tan-pink mucosa were significantly associated with pCR (p < 0.05). In contrast, a firm lesion and ulceration were frequently observed in patients with non-pCR (p = 0.02 and 0.05 respectively). Conclusions: Our study suggests that macroscopic pathologic features do correlate with pCR. Although cCR has comparable oncologic outcomes as pCR with favorable outcomes, standard criteria of cCR should first be defined so NCRT patients can safely be selected for observation only. [Table: see text]

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